- Regeneron Pharmaceuticals (Troy, NY)
- The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and ... for all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory Intelligence, a typical day might include the following +… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic Products) Date: Jun 13, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC ...in scientific discipline. ⦁ Minimum 10 years of pharmaceutical industry experience. ⦁ Minimum 6 years of Regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. **Sr Director , CMC Regulatory Affairs -Small Molecules** **KEY RESPONSIBILITIES** ... The Sr Director , CMC Regulatory Affairs for Small Molecules is...business process development initiatives or represent the company in industry consortia. **QUALIFICATIONS** + A scientific degree with directly… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you will provide program ... leadership and develop CMC regulatory strategy for global vaccine programs...to teams and line management. + Active participation in Agency/ Industry groups/forums preferred. + Some international travel may be… more
- Gilead Sciences, Inc. (Foster City, CA)
- …be accountable for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. ... Gilead and help create possible, together. **Job Description** The Associate Director , Analytical Regulatory Science, collaborates with product development,… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule...CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.… more
- AbbVie (North Chicago, IL)
- …abreast of developments in global technical, regulatory and compliance arena and industry practice. + Apprises CMC Management of plans and risks through ... CMC activities with respect to science, technology, quality, regulatory /compliance requirements, budget and resources. *Must possess good scientific writing… more
- AbbVie (North Chicago, IL)
- …abreast of developments in global technical, regulatory and compliance arena and industry practice. + Apprises CMC Management of plans and risks through ... strategy is closely aligned with the clinical and regulatory development strategy. May lead multiple PPDST/ CMC teams from GLP tox through IND and cPoC towards… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …project development preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for ... of experience with at least 2 + years within CMC Development in the pharmaceutical/biopharmaceutical industry preferred - 4 or More Years Ability to prioritize… more
- Lilly (Philadelphia, PA)
- …and cost targets. + Collaborate with cross-functional team leaders, including development, CMC regulatory , manufacturing, and supply chain teams, to ensure ... approval of asset in region. + Stay updated on industry trends, technological advancements, and regulatory changes...projects and programs. + Advanced understanding of cGMPs and CMC regulatory requirements + Ability to manage… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …of our academic community. **Description** The Goizueta Business School is seeking a Director to lead the career development and recruiting efforts for the newly ... in Management (MiM) Program. Reporting to the Assistant Dean & Executive Director for the Undergraduate Career Management Center and collaborating closely with the… more
- WuXi AppTec (Philadelphia, PA)
- …Overall responsibility for the analytical strategy, execution, tracking, and preparation of regulatory filing documents for the analytical part of cell and gene ... projects, ensuring timely and high-quality delivery **Responsibilities** * Provide analytical CMC -related support for new working order signing at BD, participate in… more
- Gilead Sciences, Inc. (Foster City, CA)
- …accountable for leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. The ... countries worldwide, with headquarters in Foster City, California._ **Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES...incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical, may be called upon to guide a ... to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also works...support marketing product claims. + Acts as liaison between Regulatory Affairs & CMC and other functional… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC ...- 7 or More Years 8+ years in pharmaceutical/biopharmaceutical industry experience with a focus on small molecules and… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Pharmaceutical Sciences Program Leadership where you will be responsible for ... Sciences Early-Stage Portfolio team, you will report to Pharmaceutical Sciences ( CMC ) Early-Stage Portfolio Leader and mentor and cultivate best practices in… more
- Sanofi Group (Cambridge, MA)
- …products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global R&D. ... **Job title: Device Regulatory Lead (Associate Director )** + Location:...You will be expected to proactively initiate discussions with regulatory authorities and contribute to industry standards… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global regulatory ... biologics/vaccines, and in the rare disease space. In this role, the Director defines and implements regulatory strategies; works with cross-functional project… more
- Arvinas (New Haven, CT)
- …For more information, please visit www.arvinas.com . **Position Summary** The Executive Director , Global Regulatory Strategy is responsible for designing and ... of drug development and registration experience gained from working in the pharmaceutical industry or a regulatory authority in one or more regions (US… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**Summary** The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities from early development ... serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team...Qualifications** - 7 or More Years in the pharmaceutical industry with significant experience in scientific/ regulatory fields… more